Syringe dose and position measuring apparatus

ABSTRACT

An injection system can have a Syringe Dose and Position Apparatus (SDPA) mounted to a syringe. The SDPA can have one or more circuit boards. The SDPA can include one or more sensors for determining information about an injection procedure, such as the dose measurement, injection location, and the like. The SDPA can also include a power management board, which can be a separate board than a board mounted with the sensors. The syringe can also include a light source in the needle. Light emitted from the light source can be detected by light detectors inside a training apparatus configured to receive the injection. The syringe can have a power source for powering the sensors and the light source. The SDPA and the power source can be mounted to the syringe flange.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application claims benefit of U.S. Provisional Patent ApplicationNo. 62/449531, filed Jan. 23, 2017, and entitled “SYRINGE DOSE ANDPOSITION MEASURING APPARATUS,” and U.S. Provisional Patent ApplicationNo. 62/552307, filed Aug. 30, 2017, and entitled “SYSTEMS AND METHODS OFINJECTION TRAINING,” the entire disclosure of each of which is herebyincorporated by reference and made part of this specification.

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference in their entirety under37 CFR 1.57.

FIELD

The present disclosure generally relates to the field of injectablemedication, in particular, to cosmetic and therapeutic injection and/orinjection training devices and systems.

BACKGROUND

A variety of medical injection procedures are often performed inprophylactic, curative, therapeutic, or cosmetic treatments. Injectionsmay be administered in various locations on the body, such as under theconjunctiva, into arteries, bone marrow, the spine, the sternum, thepleural space of the chest region, the peritoneal cavity, joint spaces,and internal organs. Injections can also be helpful in administeringmedication directly into anatomic locations that are generating pain.These injections may be administered intravenously (through the vein),intramuscularly (into the muscle), intradermally (beneath the skin),subcutaneously (into the fatty layer of skin), or by way ofintraperitoneal injections (into the body cavity). Injections can beperformed on humans as well as animals. The methods of administeringinjections typically vary for different procedures and may depend on thesubstance being injected, the needle size, or the area of injection.

Injections are not limited to treating medical conditions, such ascancer and dental treatment, but may be expanded to treating aestheticimperfections, restorative cosmetic procedures, procedures for treatingmigraine, depression, lung aspirations, epidurals, orthopedicprocedures, self-administered injections, in vitro procedures, or othertherapeutic procedures. Many of these procedures are performed throughinjections of various products into different parts of the body. Theaesthetic and therapeutic injection industry includes two maincategories of injectable products: neuromodulators and dermal fillers.The neuromodulator industry commonly utilizes nerve-inhibiting productssuch as Botox®, Dysport®, and Xeomin®, among others. The dermal fillerindustry utilizes products administered by providers to patients fororthopedic, cosmetic and therapeutic applications, such as, for example,Juvederm®, Restylane®, Belotero®, Sculptra®, Artefill®, Voluma®,Kybella®, Durolane®, and others. The providers or injectors may includeplastic surgeons, facial plastic surgeons, oculoplastic surgeons,dermatologists, orthopedist, primary care givers,psychologist/psychiatrist, nurse practitioners, dentists, and nurses,among others.

SUMMARY

The current state of the art utilizes a syringe with a cylindrical bodyand a plunger that moves within the body. The body has a discharge endthat can attach to a needle or IV for delivery of medication. The doseof medication delivered is determined by viewing the plunger travel inrelation to graduations visible on the clear wall of syringe body.

The present disclosure provides an improved syringe system for training,tracking, monitoring and providing feedback to a user. Some or allaspects of the injection systems and methods of the present disclosurecan be used for both injection training and medication deliveryinjections in live patients.

The present disclosure can include an injection syringe of the injectionsystem having a Syringe Dose and Position Apparatus (SDPA). The SDPA canhave one or more printed circuit boards. The SDPA can be mounted to asyringe flange or be configured to be moved elsewhere on the syringe.The SDPA can have a controller, such as a microprocessor, and one ormore sensors, such as plunger motion sensor, inertial navigation system(INS). The SDPA can include or be connected to a power source.

The SDPA can improve the knowledge of medication delivered. Theknowledge can include, for example, the time of delivery, type ofmedication, the amount of medication delivered, the location ofdelivery, and/or the identity of the user to validate that the userpurchased the medication product from a manufacturer with regulatoryapproval, such as with FDA approval in the US, with CE marks, or theregulatory bodies in other countries.

The SDPA can have a plunger motion sensor for measuring plunger travelthat does not rely on viewing graduation. The plunger travelmeasurements can be made using various sensors, for example, a rotarypotentiometer, a linear resistance potentiometer, a magnetometer, or thelike. The sensor for plunger travel measurements can be at leastpartially located on the SDPA. The plunger travel measurements describedherein are advantageous over relying on viewing graduations on thesyringe body, which can be subjective and/or less accurate. Thesensor-based plunger travel measurements can also be collected andrecorded, which can include not only the dose, but also time ofdelivery, type of medication, location of delivery, identity of theuser, authenticity of the product (for example, that the product is notimported) among other types of information.

Sensor-based injection systems and methods of the present disclosure cancollect, process, analyze, and display other measured informationassociated with the delivery of an injection, including but not limitedto measurements of a syringe's position and orientation in thethree-dimensional space. The measured information can be obtained andprocessed to provide performance metrics of an injection procedure. Theposition and orientation measurement can be performed by anaccelerometer, a gyroscope, a magnetometer, or a combination thereof.

The power source can supply power for the sensors, processors,communication components. The power source also optionally power a fiberoptic embedded within the needle tip. Light emitted from the needle tipcan be detected by one or more cameras inside an injection traininganatomical model to also provide position and/or orientation informationabout the needle tip. One or more cameras external to the training modelor live patient can also be used to track the location of the syringe.

The SDPA can also include one or more wireless communication components,such as Bluetooth, radiofrequency antenna, and the like. The collectedinjection information can be transmitted to a remote receiver. Thecollected injection information can also be combined with a digitalmodel of a training apparatus to deliver a computer-generated, graphicaldepiction of the training procedure, enabling visualization of theinjection from perspectives unavailable in the physical world. Theperformance metrics can be available at the time of the injection toguide the injector. The injection procedure, as reflected in themeasured sensor-based data, can also be reviewed and analyzed at timesafter, and in locations different than, the time and location of thetraining injection. Additionally, injection data associated withmultiple injections can be recorded, aggregated and analyzed for, amongother things, trends in performance.

A flange of the present disclosure can be configured for use on aninjection syringe. The flange can comprise a flange housing, wherein theflange housing includes an internal compartment; and at least onecircuit board mounted within the internal compartment, wherein the atleast one circuit board comprises one or more sensors, the one or moresensors configured to measure injection information about an injectionprocedure performed using the injection system. The flange can furthercomprise a flange base and a flange cover, wherein the flange base andflange cover are configured to be assembled to form the internalcompartment. The flange base can be an integral part of a syringe body,the flange cover comprising one or more slots configured to slidablyaccommodate the flange base. The flange can be configured to be clippedonto a flange portion of the syringe. The flange base can comprise aslot on a distal surface, the slot configured to slidably accommodatethe flange portion of the syringe. The flange can comprise an openingsized to accommodate a plunger of the syringe. The at least one circuitboard can comprise a plunger travel sensor, a force sensor, a pressuresensor, a magnetic sensor, and/or a medication code reader. The at leastone circuit board can comprise a first circuit board and a secondcircuit board. The first and second circuit boards can be stacked.

An injection system of the present disclosure can comprise a syringehaving a syringe body and a plunger, the plunger configured to moverelative to the syringe body, the syringe body configured to be coupledto a needle; the syringe body comprising a body portion having aproximal end and a distal end, a flange disposed at or near the proximalend, and a needle coupling portion disposed at or near the distal end;at least one circuit board mounted to the syringe body; and one or moresensors mounted to the syringe body and/or plunger and configured tomeasure injection information about an injection procedure performedusing the injection system. The injection information can comprise oneor more of time of injection; type of medication; authenticity ofmedication; injection dose; identity of user of the system; and/orlocation of injection. The system can be configured for providinginjection to a live patient and/or a training apparatus. The trainingapparatus can comprise an anatomical model. The one or more sensors cancomprise one or more of: a position sensor, a potentiometer, an opticalsensor, a force sensor, a pressure sensor, a magnetic sensor, and/or amedication code reader. At least one of the one or more sensors can bemounted on the at least one circuit board. The at least one circuitboard can further comprise one or more controller. The at least onecircuit board can be releasably attached to the syringe. The system canfurther comprise a housing for the at least one circuit board. Thehousing can be mounted to the flange of the syringe body. The housingcan be clipped onto the flange. The at least one circuit board cancomprise an opening configured to slidably accommodate the plunger. Thesystem can further comprise a power source, wherein the at least onecircuit board can be configured to be in electrical contact with thepower source. The power source can be located within the housing. The atleast one circuit board can comprise a first circuit board and a secondcircuit board. The first and second circuit boards can be at leastpartially stacked. The first circuit board can comprise at least one ofthe one or more sensors. The second circuit board can comprise a powermanagement board. The first and second circuit boards can be mountedsubstantially to one side of the flange, and the power source can bemounted to a diametrically opposite side of the flange. The at least onecircuit board can comprise a rotary sensor configured for measuring aplunger travel. A shaft of the plunger can comprise a helical groovesuch that a transverse cross-section of the shaft can be substantiallyD-shaped. The rotary sensor can be keyed to the D-shaped shaft such thata linear movement of the shaft relative to the syringe body causesrotation of the rotary sensor. The shaft can further comprise a channelsubstantially parallel to a longitudinal axis of the shaft. The rotarysensor can comprise a protrusion configured to engage the channel so asto prevent rotation of the rotary sensor upon rotation of the plungerwithout linear moving the plunger. The at least one circuit board cancomprise two electrical contacts configured to measuring a plungertravel. The two electrical contacts can be biased radially inwardly. Ashaft of the plunger can comprise a resistance strip, the two electricalcontacts configured to be in contact with the resistance strip duringlinear movement of the plunger. The plunger travel measurement can bebased at least in part on resistance changes measured between the twoelectrical contacts. The at least one circuit board can comprise amagnetic field sensor configured to measure changes in a magnetic fieldof a magnet located on the plunger, the plunger travel measurement basedat least in part on the changes in the magnetic field. The dosemeasurement can be calculated as a product of the plunger travel and aninternal cross-section area of the syringe body. The system can furthercomprise a light source at or near the distal end of the needle couplingportion of the syringe. The light source can comprise an LED. The lightsource can be powered by the power source. The syringe can comprise awire lumen through a syringe wall, the wire lumen configured toaccommodate an electrical connector connecting the power source and thelight source. The system can further comprise a fiber optic extendingbetween the light source and a tip of the needle. The fiber optic can befused to a lumen of the needle. The fiber optic can comprise a diffuserlayer at or near the tip of the needle. Light emitted from the needletip can be configured to be detected by one or more light detectorslocated within a cavity of the training apparatus. The injection systemcan be configured to determine a three-dimensional position of theneedle based at least in part on the light detected by the one or morelight detectors. The injection system can be configured to determine athree-dimensional position and/or orientation of the syringe based atleast in part on fusing data from the one or more light detectors andthe position sensor. The system can further comprise a charging base,wherein the power source can be rechargeable by docking the syringe bodyonto the charging base. The syringe can comprise one or more electricalpads connected to the at least one circuit board. The charging base cancomprise one or more electrical connectors, the electrical connectorsconfigured to make contact with the electrical pads when the syringebody can be docked onto the charging base. The one or more electricalconnectors can comprise pogo pins. The plunger can comprise a biometricsensor, the biometric sensor configured to detect identity of a personperforming the injection. The biometric sensor can comprise afingerprint sensor located on a thumb portion of the plunger. The atleast one circuit board can comprise wireless communication connectors.The wireless communication connectors can comprise Bluetooth Low Energy.The system can further comprise a remote wireless receiver configured toreceive data transmitted from the at least one circuit board. The systemcan further comprise a remote server configured to receive, analyze,and/or store data received by the remote wireless receiver. The systemcan further comprise a plunger stopper configured to apply a resistanceto the plunger movement. The stopper can comprise a gear positioned ator near a path of the plunger movement. The stopper can be configuredstop the plunger from moving when the system detects a predetermineddose has been delivered. The resistance can also be configured tosimulate viscosity of the mediation.

An injection system of the present disclosure can comprise a syringehaving a syringe body and a plunger, the plunger configured to moverelative to the syringe body, the syringe body configured to be coupledto a needle; the syringe body comprising a body portion having aproximal end and a distal end, and a needle coupling portion disposed ator near the distal end; a flange disposed at or near the proximal end ofthe syringe body, the flange comprising an internal compartment; and atleast one circuit board disposed within the internal compartment,wherein the at least one circuit board can comprise one or more sensors,the one or more sensors configured to measure injection informationabout an injection procedure performed using the injection system. Theinjection information can comprise one or more of time of injection;type of medication; authenticity of medication; injection dose; identityof user of the system; and/or location of injection. The system can beconfigured for providing injection to a live patient and/or a trainingapparatus. The training apparatus can comprise an anatomical model. Theone or more sensors can comprise one or more of: a position sensor, apotentiometer, an optical sensor, a force sensor, a pressure sensor, amagnetic sensor, and/or a medication code reader. At least one of theone or more sensors can be mounted on the at least one circuit board.The system can further comprise a housing for the at least one circuitboard. The housing can be releasably attached to the flange of thesyringe body.

An injection system of the present disclosure can comprise a syringehaving a syringe body and a plunger, the plunger configured to moverelative to the syringe body, the syringe body configured to be coupledto a needle; and the syringe body comprising a body portion having aproximal end and a distal end, a flange disposed at or near the proximalend, and a needle coupling portion disposed at or near the distal end;wherein the flange can comprise a medication code containing informationabout a medication contained in the syringe body, and wherein the flangecan be configured to mate with at least one circuit board, the circuitboard comprising a medication code reader configured to obtaininformation from the medication code. The system can further comprisethe at least one circuit board, wherein the at least one circuit boardcan comprise one or more additional sensors, the one or more additionalsensors configured to measure injection information about an injectionprocedure performed using the injection system. The system can furthercomprise a housing for the at least one circuit board. The housing canbe releasably attached to the flange of the syringe body.

An injection system of the present disclosure can comprise a syringehaving a syringe body and a plunger, the syringe body configured to becoupled to a needle, the plunger configured to move relative to thesyringe body, wherein the plunger comprises a plunger shaft having ahelical groove along a longitudinal axis of the plunger shaft; thesyringe body comprising a body portion having a proximal end and adistal end, a flange disposed at or near the proximal end, and a needlecoupling portion disposed at or near the distal end; and a plungertravel sensor disposed on the flange, wherein the plunger travel sensorcan comprise an opening sized and shaped to slidably engage the plungershaft so that the plunger travel sensor rotates along the helical grooveas the plunger shaft moves axially along the longitudinal axis of theplunger shaft, and wherein the plunger travel sensor can be configuredto measure an axial plunger travel distance based on an amount ofrotation of the plunger travel sensor. The plunger shaft can comprise agenerally D-shaped transverse cross-section. The plunger travel sensorcan comprise a bearing configured to rotate along the he helical grooveas the plunger shaft moves axially along the longitudinal axis of theplunger shaft. The plunger travel sensor can be configured to measurethe axial plunger travel distance based on an angular position of thebearing. The plunger shaft can comprise a channel running substantiallyparallel to the longitudinal axis. The plunger travel sensor cancomprise a radially inward protrusion configured to engage the channelwhen the plunger shaft moves axially, the protrusion can remainstationary when the plunger shaft moves axially. The plunger travelsensor can be located on a circuit board. The circuit board can furthercomprise one or more additional sensors. The one or more additionalsensors can comprise a position sensor, an optical sensor, a forcesensor, a pressure sensor, a magnetic sensor, and/or a medication codereader. The system can further comprise a housing for the at least onecircuit board. The housing can be releasably attached to the flange ofthe syringe body. The system can be configured to calculate a dosemeasurement based at least in part on the axial plunger travel distance.The system can further comprise a plunger stopper configured to apply aresistance to the plunger movement. The stopper can comprise a gearpositioned at or near a path of the plunger movement. The stopper can beconfigured stop the plunger from moving when the system detects apredetermined dose has been delivered. The resistance can also beconfigured to simulate viscosity of the mediation.

An injection system of the present disclosure can comprise a syringehaving a syringe body and a plunger, the syringe body configured to becoupled to a needle, the plunger configured to move axially relative tothe syringe body; the syringe body comprising a body portion having aproximal end and a distal end, and a needle coupling portion disposed ator near the distal end; and a plunger travel sensor operably coupled tothe plunger and/or the syringe body, the plunger travel sensorconfigured to measure an electrical resistance change when the plungermoves axially relative to the syringe body, the plunger travel sensorfurther configured to calculate a plunger travel distance based at leastin part on the electrical resistance change. The plunger travel sensorcan comprise a rotary sensor configured to be slidably coupled with theplunger, the plunger comprising a helical profile, the rotary sensorconfigured to rotate along the helical profile when the plunger movesaxially relative to the syringe body, wherein the rotary sensor can beconfigured to determine the plunger travel distance based at least inpart on an amount of rotation of the rotary sensor when the plungermoves axially relative to the syringe body. The plunger travel sensorcan comprise a resistive strip disposed on the plunger and twoelectrical contacts disposed on the syringe body, the electricalcontacts configured to be in contact with the resistive strip when theplunger moves relative to the syringe body. The system can be configuredto detect a resistance increase as the plunger shaft moves distally anda resistance decrease as the plunger shaft moves proximally.

An injection system of the present disclosure can comprise a syringehaving a needle, the needle comprising an optic fiber disposed within alumen of the needle, the optic fiber terminating distally at or near atip of the needle; the syringe further comprising a syringe body and aplunger, the plunger configured to move axially relative to the syringebody; and the syringe body comprising a body portion having a proximalend and a distal end, a flange portion at the proximal end, and a needlecoupling portion disposed at or near the distal end, the syringe bodyfurther comprising a light source disposed at or near the distal end;wherein when the needle is coupled to the needle coupling portion of thesyringe body, the optic fiber can be coupled to a power source so as todirect light emitted by the light source out through the tip of theneedle, the power source also configured to power the light source. Theoptic fiber can extend proximally from a proximal end of the needle. Theoptic fiber can have a numerical aperture of at least about 0.37. Theoptic fiber can be fused with the lumen of the needle. The light sourcecan comprise an LED. The needle can be releasably coupled with theneedle coupling portion. The needle can be releasably coupled with theneedle coupling portion by M3 threads. The power source can be mountedto the flange portion, the syringe body portion comprising a wire lumen,one or more lead wires extending from the power source through the wirelumen, the one or more lead wires terminating at or near the distal endof the syringe body portion. The needle can be configured to puncture asurface of a training apparatus, the training apparatus comprising aninternal cavity and at least one light detector inside the internalcavity, the at least one light detector configured to detect light fromthe needle.

An injection system of the present disclosure can comprise a syringehaving a syringe body and a plunger, the plunger configured to moverelative to the syringe body, the syringe body configured to be coupledto a needle; the syringe body comprising a body portion having aproximal end and a distal end, and a needle coupling portion disposed ator near the distal end; a flange disposed at or near the proximal end ofthe syringe body, the flange comprising an internal compartment; atleast one circuit board disposed within the internal compartment,wherein the at least one circuit board comprises one or more sensors,the one or more sensors configured to measure injection informationabout an injection procedure performed using the injection system; and arechargeable power source configured to at least power the at least onecircuit board. The system can further comprise a charging base. Thecharging base can comprise a cradle shaped to accommodate the syringe ora portion of the syringe. The flange can comprise at least oneelectrical contact in electrical connection with the at least onecircuit board, and wherein the charging base can comprise at least onecharging contact, the at least one electrical contact configured to makecontact with the at least one charging contact when the syringe or aportion of the syringe is position on the charging base. The at leastone charging contact can comprise at least one pogo pin.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the embodiments. Furthermore, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure. Corresponding numerals indicatecorresponding parts.

FIG. 1A illustrates schematically a perspective view of an exampleinjection syringe and a remote receiver receiving data transmitted fromthe syringe.

FIG. 1B illustrates schematically a system diagram of an injectionsystem.

FIG. 1C illustrates schematically a block diagram of an injection systemcontroller or processor interacting with sensor inputs and outputtinginjection information outputs.

FIG. 2 illustrates schematically a cross-section of the syringe of FIG.1A.

FIG. 3A illustrates schematically a partially exploded view of thesyringe of FIG. 1A showing a Syringe Dose and Position Apparatus (SDPA)that can be attached to the syringe flange.

FIG. 3B illustrates schematically a cross section of a portion of thesyringe at a needle end.

FIG. 4A illustrates an example injection syringe.

FIG. 4B illustrates the syringe of FIG. 4A with a housing removed toshow the SDPA.

FIG. 4C illustrates a plunger of the syringe of FIG. 4A.

FIG. 4D illustrates a transverse cross-section of the plunger of FIG.4C.

FIG. 4E illustrates a front perspective view of an example SDPA having adual-board configuration.

FIG. 4F illustrates a side view of the SDPA of FIG. 4E.

FIG. 4G illustrates a back perspective view of the SDPA of FIG. 4E.

FIG. 4H illustrates a front view of the SDPA of FIG. 4A modified toinclude a gear.

FIG. 5A illustrates a detailed view of the syringe of FIG. 4A near theflange with portions of the syringe body, the flange and the plungerremoved for illustration purposes.

FIG. 5B illustrates schematically a block diagram of the SDPA of FIG. 4Ainteracting with other components of the syringe.

FIG. 5C illustrates schematically a flow chart of an example method ofplunger travel measurement.

FIG. 6 illustrates a perspective view of an SDPA housing base.

FIG. 7 illustrates a detailed view of an example syringe near the flangeshowing an example SDPA with a single-board configuration.

FIG. 8A illustrates an exploded view of a syringe body including a bodyportion and a needle-coupling portion.

FIG. 8B illustrates a cross-section of the syringe body of FIG. 8A.

FIG. 8C illustrates a bottom view of the body portion of the syringebody of FIG. 8A.

FIG. 8D illustrates a top view of the needle coupling portion of thesyringe body of FIG. 8A.

FIG. 9A illustrates a top view of the injection syringe of FIG. 4A.

FIG. 9B illustrates the injection syringe of FIG. 4A with the needleremoved.

FIG. 9C illustrates the needle of the syringe of FIG. 4A.

FIG. 10 illustrates schematically an example syringe with a linearresistance plunger motion sensor.

FIG. 11A illustrates schematically an example syringe with a magneticsyringe tracking sensor.

FIG. 11B illustrates schematically a flow chart of an example method ofsyringe position and/or orientation determination.

FIG. 12A illustrates schematically an example syringe withneedle-in-blood-vessel detection features.

FIG. 12B illustrates schematically a pressure drop profile for a flow ofmedication exiting a syringe into body tissues.

FIG. 12C illustrates schematically a flow chart of an example method ofdetecting needle in artery.

FIG. 13 illustrates an example syringe charging base.

FIG. 14A illustrates another example syringe charging base loaded with asyringe.

FIG. 14B illustrates a detailed view of charging features of thecharging base and the syringe flange.

FIG. 15 illustrates schematically an example syringe cradle with asyringe.

DETAILED DESCRIPTION

Aspects of the disclosure are provided with respect to the figures andvarious embodiments. One of skill in the art will appreciate, however,that other embodiments and configurations of the devices and methodsdisclosed herein will still fall within the scope of this disclosureeven if not described in the same detail as some other embodiments.Aspects of various embodiments discussed do not limit scope of thedisclosure herein, which is instead defined by the claims following thisdescription.

Example Injection Systems

The present disclosure provides various systems and methods ofperforming an injection procedure for actual medication delivery and/orinjection training. Although the descriptions herein may be in thecontext of cosmetic facial injections, the injection systems and/ormethods described herein can be configured for use in any part of thepatient's body, any part of an animal's body, a training apparatus,and/or for any types of injections.

As shown in FIGS. 1A-2, the injection system 10 can include an injectionsyringe 100. The injection syringe 100 can have a plunger 110 configuredto move relative to a syringe body 130. The plunger 110 can include aplunger head 112, a plunger shaft 114, and a piston 116. The syringebody 130 can include a flange portion 134, a body portion 138, and aneedle coupling portion 142. The body portion 138 can have a lumen forcontaining an injection material, or medication 20. The syringe 100 canhave a needle 150 coupled to the needle coupling portion 142 of thesyringe body 130. The needle 150 can be configured to deliver theinjection material or compound into an injection location on a patientand/or a training apparatus 210. Additional details of the trainingapparatus are described in U.S. Pat. No. 9,792,836, entitled “INJECTIONTRAINING APPARATUS USING 3D POSITION SENSOR,” U.S. Patent PublicationNo. 2015/0206456 A1, entitled “INJECTION SITE TRAINING SYSTEM,” U.S.Patent Publication No. 2015/0262512 A1, entitled “AUTOMATED DETECTION OFPERFORMANCE CHARACTERISTICS IN AN INJECTION TRAINING SYSTEM,” and U.S.Patent Publication No. 2017/0254636 A1, entitled “SYSTEM FOR DETERMININGA THREE-DIMENSIONAL POSITION OF A TESTING TOOL,” the disclosure of eachof which is incorporated herein by reference in its entirety.

The plunger 110, syringe body 130, and/or needle 150 can have one ormore sensors, such as a plunger motion or travel sensor 186, a positionand/or orientation sensor 191, force and/or pressure sensors 192,biometric sensor 196, medication code reader 184, and/or other types ofsensors. As will be described in greater details below, the plungermotion or travel sensor 186 can measure linear movement of the syringeplunger 110 relative to the syringe body 130. The position and/ororientation sensor 191 can measure position, such as an x-y-z position,and/or orientation of the syringe. The position and/or orientationsensor 191 can be an inertial navigation system and/or a magneticsensor. When the syringe is used for injection training, the positionand/or orientation sensor 191 can additionally or alternatively includean optical sensor. The force and/or pressure sensors 192 can measure aforce and/or pressure at which the medication 20 is delivered. Thebiometric sensor 196 can identify and/or authenticate the injector. Themedication code reader 184 can scan and obtain information related tothe medication in the syringe.

The plunger 110 can have one or more electrical circuitries. A biometricsensor 196, such as a fingerprint sensor, can be mounted on the plungerhead 112. The biometric sensor 196 can detect and/or record the identityof a person performing the injection, and/or the identity of the user tovalidate that the user purchased the medication product from amanufacturer with regulatory approval, such as with FDA approval in theUS, with CE marks, or the regulatory bodies in other countries. Thebiometric sensor 196 can be coupled to a wireless transmitter 193 fortransmitting data from the biometric sensor 196 to a controller of theinjection system 10. The syringe 100 can also optionally output text,audio and/or visual alerts to the patient receiving the injection, tothe medication manufacturer, and/or regulatory authorities if the personperforming the injection is not one qualified to perform such aninjection.

As shown in FIG. 3A, a Syringe Dose and Position Apparatus (SDPA) 180can be mounted to the flange portion 134. The SDPA 180 can be mounted onthe syringe 100 releasably or permanently. The SDPA 180 can be durable,reusable, or disposable. The flange portion 134 can have a flange base135 and a flange cover 136. The SDPA 180 can be housed within the flangecover 136. As shown in FIGS. 2 and 3A, the flange base 135 can beintegrally formed with the body portion 138 of the syringe body 130. Theflange cover 136 can have a slot 139 for slidably receiving the flangebase 135 to retain the SDPA 180.

The flange portion 134 can have a long side 146 and a short side 147,for example, by having generally a rectangular shape. The flange cover135 can have a groove 133 at or near a mid-point of the long side of theflange cover 136 such that when coupled to the flange base 136, whichalso has a long side and a short side, the flange portion 134 can formtwo finger supports on diametrically opposite sides of the syringe bodyportion 138. The flange portion 134 can also have any other shapes andneed not have two finger supports on diametrically opposite sides of thesyringe body portion 138.

As shown in FIG. 3A, the SPDA 180 can have a printed circuit board 182.The board 182 can have a groove 183 substantially aligned with thegroove 133 of the flange cover 135. Although FIG. 3A illustrates thecircuit board as having circuitry components on one side of the circuitboard, circuitry components can also be mounted on both side of thecircuit board (such as shown in FIG. 7). The SDPA 180 can have aplurality of sensors described herein, such as an optical sensor, acontact sensor, a position and/or orientation sensor (for example, aninertial navigation system, or a three-axis accelerometer, gyroscope,and magnetometer sensor). A controller 195 of the SDPA 180 can receiveinputs from the plurality of sensors. As will be described below, thesensors mounted to the SPDA 182 can be used to monitor the injectionperformance, including but not limited to the amount of medicationdelivered and/or location of delivery.

The SDPA 180 can optionally include a medication code reader 184. Theflange base 114 can optionally include a medication code 116 for themedication contained in the syringe body portion 138. When the SDPA 180is mounted to the flange portion 134, the code reader 184 can scan thecode 116 for information related to the mediation that will bedelivered. The controller 195 of the SDPA 180 can receive the medicationinformation from the code reader 184. The SDPA 180 can thus also improvethe knowledge of the injection procedure by monitoring and/or recordingthe time of delivery, the type of medication being delivered, theidentity of the injector, and the like. The syringe 100 can optionallyoutput text, audio and/or visual alerts to the patient receiving theinjection, to the medication manufacturer, and/or regulatory authoritiesif medication information indicates that the medication is counterfeit,expired, and/or otherwise unsuitable for being delivered to the patient.

The SDPA 180 can also include the wireless transmitter 193 fortransmitting the injection data to the receiver 200. The system 10 canrecord data about the injection procedure performed by a trainee usingthe injection syringe on the training apparatus or a live patient on adatabase 222 on a remote server 220 that is in communication with thereceiver 200.

The SDPA 180 can also include a power source, such as a battery 190, forat least powering the SDPA 180 including the sensors mounted on the SDPA180. When the injection system is used for injection training, the powersource 190 can also be electrically coupled, such as via electricalwires 154 or other types of electrical conductors, with a light source152 in the needle 150, such as shown in FIG. 3B. The electrical wires154 can also optionally be coupled to a conductor post 155 extendingfrom the light source 152 proximally into the lumen of the syringe body130. The light source 152 can be an LED or any other type of lightsource. The light source 152 can be a low-power light emitting diode(“LED”). The low-power LED can consume less power than a LASER LED. Thelow-power LED can thus be powered by the power source 190 of the SDPA180 with less complex circuitry than is required for driving a LASERLED. A smaller circuit board can be used with the low-power LED thanwith a LASER LED. A smaller circuit board can occupy less space on thesyringe, and can promote miniaturization of the syringe.

The light source shown in FIG. 3B can be operably coupled to an opticalfiber 156. The optical fiber 156 can be located near the needle 150 andextend between the light source 152 and the tip of the needle 150. Theoptical fiber 156 can be located within a lumen of the needle 150 andextend between the light source 152 and the tip of the needle 150. Whenthe syringe 100 is used for injection training, the needle 150 canpenetrate one or more layers of tissue-simulating materials on thetraining apparatus 210. The training apparatus 210 can be an anatomicalmodel having an appearance of a patient's anatomy, such as a head,torso, limbs, and the like. The training apparatus 210 can have one ormore light detectors 212, such as cameras, inside a cavity of thetraining apparatus 210. The light detectors 212 can be spaced apart fromone another. The light detectors 212 can detect light emitting from theneedle tip. A controller of the injection system 10 can be configured todetermine injection data, such as a three-dimensional position, of theneedle based on at least in part on data about the detected light. Aswill be described below, the controller can also determine thethree-dimensional position of the syringe needle based on combinedinformation from the position and/or orientation sensor and the detectedlight. The controller can be the controller 193 on the syringe 100 (suchas the controller on the SDPA 180), or the controller 234 on thetraining apparatus 210, and/or on the remote server 220.

The remote server 220 and/or the controller on the SDPA 180 can also bein electrical communication with a training module 232. The trainingmodule can be loaded on a training module device 239, such as acomputer, a tablet, a smartphone, or others that have a display screen.The training module 232 can receive data about the injection procedure,such as from the external receiver 200 and/or from the central server220. The training module device 230 can have a user interface 236. Thetraining module 232 can provide training instructions, scoring,feedback, and/or evaluation of an injection procedure, and/orcertification of the injector, for example, when the injector is atrainee and has passed a test for an injection technique.

As shown in FIG. 1C, the controller and/or processor 193, 234 of theinjection system 10 can receive one or more of the following inputs:position and/or orientation inputs from the inertial navigation system,position and/or orientation inputs from internal optical sensor(s),position and/or orientation inputs from external optical sensor(s) (suchas external camera(s) 240 in FIG. 1B), position and/or orientationinputs from magnetic sensor(s), plunger travel sensor inputs, biometricsensor inputs, force and/or pressure sensor inputs, and/or medicationcode reader inputs. The injection system can provide one or more of thefollowing outputs: syringe position and/or orientation outputs,injection force and/or pressure outputs, dose measurement outputs,injector identity and/or qualification outputs, and/or medicationinformation outputs.

FIGS. 4A to 9C illustrate an example syringe 400. The syringe 400 canhave any of features of the syringe 100. Features of the syringe 100 canbe incorporated into features of the syringe 400 and features of thesyringe 400 can be incorporated into features of the syringe 100.

The injection syringe 400 can have a plunger 410 configured to moverelative to a syringe body 430. The syringe body 430 can include aflange portion 434, a body portion 438, and a needle coupling portion442. The flange portion 434 can protrude radially outwardly from thebody portion 438 and can be of any shape. The flange portion 434 can beat a proximal end of the syringe body 430. As shown in FIG. 4A, theflange portion 434 can be integrally formed with the body portion 438.The syringe 400 can also include an SDPA 480 (shown in FIG. 4B). TheSDPA 480 can be enclosed in a housing. The housing can be mounted to theflange portion 434 or anywhere on the syringe 400. The housing and theSDPA 480 can be releasably or permanently mounted to the syringe. Thehousing can have a cover 435 and a base 436. The cover 435 and/or thebase 436 can have an internal compartment configured to receive the SDPA500. The cover 435 and/or the base 436 can optionally have internalguide rails, posts, or the like, for securely supporting the SDPA 480inside the housing. The housing cover 435 and base 436 can each includean opening 433 configured to slidably accommodate a plunger shaft 414.

The SDPA housing can be coupled to the flange portion 434 of the syringebody 430. As shown in FIGS. 5A and 6, the housing can be coupled to theflange portion 434 using a clip-on feature. The clip-on feature can havea slot 439 on the SDPA housing. The slot 439 can be sized to accommodatethe syringe flange portion 434. The flange portion 434 can be slidablyreceived by the slot 439 and can optionally also secured to the housingwith adhesives or other ways of securement. The flange 434 can also besecured to the housing by friction between the slot 439 and the housing.As shown in FIGS. 5A and 6, the slot 439 can be on a distal surface ofthe housing base 435. The slot can also be on any other location of theSDPA housing. Additionally or alternatively, the flange 434 can also besecured to the SDPA housing using securement features other than theclip-on feature, such as magnet(s), adhesives, and/or detent(s).

As shown in FIG. 5B, the SDPA 480 can have a plurality of sensors, whichcan be any of the sensors described herein. The SDPA 480 can have aposition and/or orientation sensor 491, a plunger travel sensor 486,and/or a medication code reader 484 configured to obtain informationfrom a medication code 416, which can be located on the flange portion434. The SDPA 480 can also include wireless communication module 493,including a radiofrequency antenna and Bluetooth low energy, or otherprotocols. The SDPA 480 can also optionally include an oscillatorcrystal 496. The oscillator crystal 496 can function as a timer. TheSDPA 480 can include a power management circuit 498. The powermanagement circuit can be in electrical contact with a power source 490.The power source 490 can be a battery, such as a rechargeable battery.The power source 490 can also include more than one battery. The batterycan have a life of about 20 mAh, about 30 mAh, about 40 mAh or more. Thepower source 490 can provide power to the SDPA 480 and/or its componentsvia the power management circuit 498. The power source 490 can alsooptionally power a light source 452 near the needle of the syringe. TheSDPA 480 can include a controller 495, such as a central processingunit. The controller 495 can receive sensor inputs from the sensors onthe SDPA 480. The controller 495 can also optionally receive inputs fromoptical sensor(s) 212 in the training apparatus, when the syringe isused for injection training. The controller 495 can determineinformation related to the injection procedure based at least in part onthe sensor inputs.

As shown in FIGS. 4B, 4E, 4F, and 5A, the SDPA 480 can have two PCBs481, 482. The circuitry components and the layout thereof on first andsecond PCBs 481, 482 are for illustrative purposes only and can bevaried. For example, the circuitry components can be on one side or bothsides of the circuit board. The two PCBs 481, 482 can be at leastpartially stacked. The first PCB 481 can include any of the sensorsdescribed herein, for example, a position and/or orientation sensor 491,a plunger travel sensor 486, and/or a medication code reader 484configured to obtain information from a medication code 416, which canbe located on the flange portion 434. The first PCB 481 can include acontroller 495, such as a central processing unit. The first PCB 481 canalso include wireless communication module 493, including aradiofrequency antenna and Bluetooth low energy, or other protocols. Thefirst PCB 481 can also optionally include an oscillator crystal 496. Theoscillator crystal 496 can function as a timer. The second PCB 482 caninclude a power management board. The power management board can be inelectrical contact with a power source 490. The power source 490 can bea battery, such as a rechargeable battery. The power source 490 can alsoinclude more than one battery. The battery can have a life of about 20mAh, about 30 mAh, about 40 mAh or more. The first and second PCBs 481,482 can be electrically coupled by one, two, or more flex circuits 485,or any other type of electrical conductors, such as board-to-boardconnectors. Although the figures illustrate the first PCB 481 stacked ontop of the second PCB 482, the second PCB 482 can be stacked on top ofthe first PCB 481.

As the SDPA housing can form two finger supports on diametricallyopposite sides of the syringe body portion 438, the stacked PCBs 481,482 can be substantially housed within one of the finger supports, witha hole 483 on the first PCB 481 to slidably accommodate the plungershaft 414. The power source 490 can be located in the other one of thefinger supports. The PCBs 481, 482, and the power source 490 can besmall enough to fit into one of the finger supports of the SDPA housing.The PCBs can have a size of about 22.9 mm×12.7 mm, or smaller. Thebattery can have a size of about 3 mm×11 mm×20 mm, or about 3 mm×12mm×15 mm, or smaller. The form factors of the PCBs and any of thecomponents on the PCBs, such as the battery and the sensors, are notlimiting. The stacked PCBs can reduce a size of the SDPA 480 and/or asize of the SDPA housing.

As shown in FIGS. 5A and 6, the housing base 436 can include a distallyfacing concave or curved surface at each of the finger supports. Thecurved surface can improve comfort and/or grip of the injector's fingerswhen manipulating the syringe 400.

The SDPA can also have a single PCB 182, such as the SDPA 180 of thesyringe 100, and as shown in FIG. 7. The sensors and/or controllercircuitry can be housed in one of the finger supports and the powermanagement board can be located in the other one of the finger supports.In FIG. 1, the power source 190 can be located on the PCB 182. In FIG.7, the power source 790 can be stacked on top of a portion of the PCB781, such as on top of the power management board. The PCB 781 in FIG. 7can also include a hole 783 at or near a center of the PCB 781. The holecan be configured for slidably accommodating the plunger shaft 714. ThePCB 781 in FIG. 7 can have a size of about 43.2 mm×8.9 mm, or about,38.1 mm×11.5 mm. The hole 783 in the PCB 781 can have a diameter ofabout 5 mm.

Turning to FIGS. 8A-8D, the body portion 438 and the needle couplingportion 442 can be manufactured as separate components. During assembly,the body portion 438 of the syringe body 430 can be releasably orpermanently coupled to the needle coupling portion 442. A distal end ofthe body portion 438 and a proximal end of the needle coupling portion442 can have corresponding coupling features, such as a hexagonal socket439 on the distal end of the body portion 438 and a hexagonal head 443on the proximal end of the needle coupling portion 442, or any othertypes of coupling features.

The body portion 438 and the flange portion 434 can have a continuous orinterconnected wire lumen 440. The wire lumen 440 can be formed in awall of the flange portion 434 and the body portion 438. The wire lumen440 can allow one or more electrical connectors, such as one or morelead wires, be extended between the power source 490 in the SDPA and thelight source, such as the light source 152 in FIG. 3B. The body portion438 and the flange portion 434 can also include more than one, such astwo wire lumens for accommodating the electrical connectors. The wirelumen 440 can terminate near the distal end of the body portion 438. Thebody portion 438 can also include one or more radially inwardprotrusions 441 at or near where the wire lumen 440 ends. Theprotrusions 441 can support and/or secure the light source inside thebody portion 438. One or more LED circuit boards can also be install ator near the distal end of the syringe body portion 438 to hold the LEDthat is installed in the bottom of the syringe tube. The one or moreelectrical connectors can connect the one or more LED circuit boards tothe SDPA 480.

The needle coupling portion 442 can have a throughlumen 444. Thethroughlumen 444 can provide a passage for the medication and/or anoptic fiber, such as the optic fiber 156 in FIG. 3B. The needle couplingportion 442 can include Luer lock connections or threads, such as M3threads, for releasably coupling the syringe body 430 to the needle 450.

As described above, an optical fiber can be located within a lumen ofthe needle and extending between the light source and the tip of theneedle. The optical fiber can be fused to the lumen of the needle. Theoptical fiber 456 can extend from a proximal end of the needle towardthe light source, such as shown in FIG. 9C. The optical fiber 456 canalso be bonded to a receptacle 451 that is connected to the needle 450.The receptacle 451 can releasably couple the needle 450 to the needlecoupling portion 442. The receptacle 451 can include Luer lockconnections or threads 453, such as M3 threads. Engagement of M3 threadson the receptacle 451 and corresponding threads 445 on the needlecoupling portion 442 can improve centering of the optic fiber 456 overthe light source, compared to the Luer lock connections.

The optic fiber can be a mono fiber optic cannula (for example, asmanufactured by Doric Lenses). The fiber can have a core diameter ofabout 100 μm. The numerical aperture of the fiber can be large forimproved input and output angle of the light, and/or for reducingsensitivity to lateral offsets of the fiber. The fiber can have anumerical aperture of about 0.37, or about 0.66, or larger. The fibercan have an outer diameter of about 0.4 mm. The needle can be a gauge 30hypotube needle, which has an internal diameter of about 0.14 mm toabout 0.178 mm. The needle can also have a larger internal diameter,such as about 0.5 mm, which can accommodate the fiber having an outerdiameter of about 0.4 mm. The needle can have a length of about 12.7 mm.

The optical fiber can optionally have a shaved optical fiber end near atip of the needle. The shaved optical fiber end can improve a bloom ofthe optical fiber end and/or provide a substantially omni-directionallight. The optical fiber can also have a diffuser layer at its distalend. The diffuser layer can spread out the output light when the lightexits the fiber and improve the bloom of the light. The substantiallyomni-directional light can have approximately equal level of intensityin substantially all the directions. The improved bloom can improvedetection of the light source with a large side profile of the needleinside the training apparatus.

The syringe need not have any of the optical sensor components, such asthe light source, the lead wire(s), the optic fiber, and the like. Thesyringe without the optical sensor can be used for delivery actualmedication to patients.

Dose Measurement Examples

As described above, the SDPA can improve the knowledge of medicationdelivered in an actual injection procedure or a training procedure,including the amount or dose that is delivered during the injection. Oneway to measure dose by the controller of the SDPA or the training moduleis based on plunger travel measurements. An example method of plungertravel measurement is illustrated in FIG. 5C. At step 571, thecontroller can optionally determine whether the SDPA has been mounted tothe syringe flange. For example, the controller can determine that theSDPA has been mounted to the syringe upon detection of a medication codeon the flange by the medication code reader described herein. If theSDPA has not been mounted to the syringe flange, at step 579, thecontroller can output an instruction to a user, such as an injector or anurse, to mount the SDPA to the syringe. If the SDPA has been mounted tothe syringe flange, at step 572, the controller can receive a signalfrom a plunger travel sensor, which can be any of the plunger travelsensor described below. At decision step 574, the controller candetermine whether a change in the signal, such a change in resistance ora change in the magnetic field, can be detected. If no change has beendetected, the controller can return to the step 572. If a change in thesignal has been detected, at step 576, the controller can calculate thelinear movement of the plunger, or the plunger travel based at least inpart on the change in the signal. At step 578, the controller canoptionally calculate the volume of the medication delivered bymultiplying the distance traveled by the plunger and the internalcross-sectional area of the syringe body portion.

The SDPA can measure plunger travel that does not rely on viewinggraduation. The plunger travel measurements can be made using varioussensors, for example, a rotary potentiometer, a linear resistancepotentiometer, a magnetometer, or the like. The sensor for plungertravel measurements can be at least partially located on the SDPA. Theplunger travel measurements described herein are advantageous overrelying on viewing graduations on the syringe body, which can besubjective and/or less accurate. The sensor-based plunger travelmeasurement data can also be collected and recorded to a server withouthaving to be manually entered, and can be combined with other types ofinjection data, such as the time of delivery, type of medication,location of delivery, among other types of information.

The injection system can also optionally simulate viscosity of themedication by adding resistance to the plunger. The injection system canadjust the magnitude of the resistance based on the medicationinformation read by the code reader on the SDPA. The resistance appliedto the plunger can also be large enough to cause a complete stop ofplunger travel, such as plunger travel toward the distal end and/orproximal end of the syringe body. The complete stop resistance can beactivated when the injection system determines that an intended amountor dose of the medication has been delivered. The stop feature canprevent overdose and/or promote injection safety.

Rotary Potentiometer

As shown in FIGS. 4A-4D, the plunger shaft 414 can be generallycylindrical. The shaft 414 can have a helical or substantially helicalgroove 415 along a longitudinal axis of the plunger shaft 414. As shownin FIG. 4D, the helical groove 415 can result in a transversecross-section of the plunger shaft 414 being generally D-shaped. Thehelical groove 415 can rotate about 270 degree. The helical groove 415can have a length of about 50 mm to about 100 mm, or about 76 mm per 360degree. The plunger shaft 414 can also have a helical profile with adifferent linear distance per revolution.

The SDPA 480 can include a keyed rotary sensor or potentiometer 486 (seeFIG. 4B). The rotary sensor 486 can be a hollow-shaft type sensor. Therotary sensor 486 can have a stationary housing 487 and a bearing 488.The bearing 488 can have a generally D-shaped opening 489. The opening489 can be configured to slidably accommodate the generally D-shapedplunger shaft 414. The bearing 488 can rotate along the helical groove415 during linear advancement of the plunger shaft 414 while permittingthe housing 487 to remain stationary. When the plunger 410 is advanceddistally toward the needle tip in a linear movement, for example, todeliver medication or simulate delivery of medication, the rotary sensor486 can monitor the angular position of the bearing 488 relative to thehousing 487. The rotary sensor 486 can calculate a distance of thelinear movement based on the amount of rotation of the helical groove415 measured by the rotary sensor 486. The amount of rotation of thehelical groove 415, that is, the angular position of the bearing 488,can be determined based on a change of resistance of the rotary sensor486 due to the rotation of the bearing 488.

The plunger shaft 414 can further include a substantially straightchannel 417 along the longitudinal axis of the plunger shaft 414 (seeFIG. 4C). The stationary housing 487 of rotary sensor 486 and/or thecircuit board can have a corresponding protrusion, such as a tab thatengages the channel 417. FIG. 4E illustrates the protrusion 418 on thefirst PCB 481 underneath the sensor housing 487. The protrusion 418extends radially inwardly into the opening 489 of the bearing 488. Theengagement between the protrusion 481 and the channel 417 can preventthe rotary sensor 486 from converting a pure rotation of the plunger 410into a measurement of linear movement of the plunger 410. This isbecause when a force is applied to try to rotate the plunger 410 withoutaxially moving the plunger 410, the engagement between the protrusion481 and the channel 417 can prevent rotation of the plunger 410 and/orthe bearing 488. However, when the plunger 410 is moved axially, theengagement between the protrusion 481 and the channel 417 forces thebearing 488 to rotate along the helical profile formed by the helicalgroove 415. The engagement forces the rotary sensor 486 to rotate onlyby linear translation of the plunger 410.

The rotary sensor 486 can also optionally include a gear 497 (see FIG.4H) on a proximal surface of the sensor 486. The gear 497 can also bekeyed to the plunger 410 with the helical profile and can rotate as theplunger 410 moves axially. The gear 497 can optionally add resistance tothe plunger travel. The gear 497 can be configured to vary theresistance added to the plunger travel based on the medicationinformation read by the code reader on the SDPA. The gear 497 can beconfigured to vary the resistance to the plunger travel by varying theamount of friction required to turn the gear.

Linear Resistance Potentiometer

A resistance change directly corresponding to the linear movement of theplunger can also be measured. The syringe plunger can include aresistance strip extending generally parallel to the longitudinal axisof the plunger shaft. The resistance strip can have a conductive paint(for example, carbon- or graphite-based paint, copper-based paint,silver-based paint, or any other conductive compound(s)). The conductivepaint can provide electrical resistance when a strip of the conductivepaint is connected to an electrical circuit.

FIG. 10 schematically illustrates an example syringe 1000 with a linearresistance-based plunger position detecting feature. The syringe 1000can have any of features of the syringe 100, 400. Features of thesyringe 100, 400 can be incorporated into features of the syringe 1000and features of the syringe 1000 can be incorporated into features ofthe syringe 100, 400.

As shown in FIG. 10, the linear resistance-based plunger positiondetecting feature can include a resistance strip 1015 and a pair ofelectrical contacts 1037. The plunger 1010 can have a thumb portion 1012on a proximal end of the plunger 1010 and a shaft portion 1014 extendingfrom the thumb portion 1012 to a distal end of the plunger 1010. Theshaft portion 1014 can be generally cylindrical. The conductive orresistance strip 1015 can start on a first radial side of the shaftportion 1014 at or near the thumb portion 1012. The resistance strip1015 can extend generally along the longitudinal axis of the plungershaft portion 1014 to the distal end of the plunger 1010, continueacross (for example, diametrically across) a distal surface of the shaftportion 1014, and extend back toward the thumb portion 1012 along thelongitudinal axis on a second radial side, generally opposite the firstradial side, of the shaft portion 1014.

As shown in FIG. 10, the syringe body 1030 can have a flange 1034 at ornear a proximal end of the syringe body 1030. The flange 1034 cansupport or enclose two springy or spring-loaded contacts 1037 (such asconductive wires or conductive strips). The contacts 1037 can be locatedgenerally diametrically opposite each other and can extend radiallyslight over the wall of the syringe body and into the syringe lumen. Thecontacts can be electrically coupled to the SDPA 1080. The flange 134can further include a power source 1090 located diametrically oppositethe SDPA 1080.

When the shaft portion 1014 of the plunger 1010 is inserted distallyinto the syringe body 1030 end and translates relative to the syringebody 1030, each of the contacts 1037 can make contact, such as firmcontact, with the resistance strip 1015 on the first or second radialside. Contacts established between the resistance strip 1015 and thecontacts 1037 can complete an electrical circuit. A portion of theresistance strip 1015 connecting the two contacts 1037 can provideresistance in the circuit. As indicated by the arrow in FIG. 10, alength of the resistance strip 1015 that connects the two contacts 1037in forming an electrical circuit can vary as the plunger 1010 movesaxially relative to the syringe 1030. When the plunger 1010 movesproximally relative to the syringe body 1030 and away from the needle1050, the portion of resistance strip 1015 connecting the contacts 1037can decrease in length. The resistance measured by the circuit candecrease. When the plunger 1010 moves distally relative to the syringebody 1030 and toward the needle 1050, the portion of resistance strip1015 connecting the contacts 1037 can increase in length. The resistancemeasured by the circuit can increase.

The one or more processors or controllers on the syringe 1000, such ason the SDPA described above, can be configured to monitor the resistancereadings between the contacts 1037. The one or more processors can beconfigured to determine the position of the plunger 1010 relative to thesyringe body 1030 based at least in part on the resistance readings. Theprocessors can compare the resistance readings to a look-up table,compute the plunger travel using an equation, or others.

The electronics for detecting resistance changes and that are on orembedded in the flange, such as on the SDPA, can be smaller thancommercially available off-the-shelf electronics, such as off-the-shelflinear encoders.

Magnetic Sensor on Plunger

The SDPA can also measure the plunger travel using a magnetic sensor 120(see FIG. 2). The plunger can include a magnetic chip. The magnetic chipcan have a permanent magnet. The magnetic chip can be located at anylocation on the plunger. The SDPA can include a magnetic field sensor121. The magnetic field sensor can detect changes in the magnetic fieldof the magnetic chip as the plunger is moved linearly relative to thesyringe body. The changes in the magnetic field can be used to measurethe plunger travel.

The one or more processors or controllers on the syringe 1000, such ason the SDPA described above, can be configured to monitor the magneticfield readings. The one or more processors can be configured todetermine the position of the plunger 1010 relative to the syringe body1030 based at least in part on the magnetic field readings. Theprocessors can compare the magnetic field readings to a look-up table,compute the plunger travel using an equation, or others.

Position and/or Orientation Detection

The one or more position and/or orientation sensors, such as amagnetometer, a gyroscope, an altimeter, and/or an accelerometer, canprovide data related to the position of the syringe to the controller ofthe injection system, such as the controller on the SDPA. The injectionsystem can determine a three-dimensional position of the syringe and/oran attitude of the syringe based at least in part on the data from theone or more position and/or orientation sensors. The attitude canprovide orientation information of the syringe in a three-dimensionalspace in addition to the x-y-z position of the syringe. The orientation,or attitude, information can include, for example, an angle at which thesyringe, more specifically, the syringe needle, is titled. When theinjection system includes the optical sensor described herein, thecamera(s) inside the training apparatus can also provide data related tothe position of the needle tip. The controller of the injection systemcan fuse the data from the position sensors and the camera(s) to improveaccuracy in determining the x-y-z position of the syringe.

Together, all the position data can be combined to providedeterminations of the position and attitude of the syringe when theneedle punctures the apparatus material. Due to the give from thetraining apparatus when the needle punctures the apparatus, estimates ofthe attitude of the syringe can provide improved accuracy in determiningan angle of insertion of the needle. The training apparatus material canadhere to the needle when the needle is pulled out of the trainingapparatus. The tugging can block the light source in the needle tip forone or more of the light detectors inside the training apparatus. Datafrom the accelerometer of the position sensor (for example, short-termdata from the accelerometer) can be combined with data from other lightdetectors that can detect the light source. The combined data canprovide an estimate of readings on the light detector with the blockedlight source. By combining all the information together to correctestimates, the processor can be configured to predict errors before theyhappen in live patients.

Processing raw data from the position sensor and/or camera(s) caninclude estimating the position and/or attitude of the syringe at a highfrequency (such as in the magnitude of thousands of Hertz or tens ofthousands of Hertz). Correcting the estimated position and attitude ofthe syringe at a high frequency can reduce drift and improve accuracy ofthe estimates. Processing raw data on the controller of the injectionsystem, such as the controller on the SDPA, can allow the controller toupdate the estimated positon and/or attitude readings, combine all theraw data from different sensors, and/or correct error at a higherfrequency. This can also improve overall accuracy of the determinationof the position and/or attitude of the syringe.

Magnetic Syringe Tracking Sensor

In addition to or alternative to the optical sensor described herein, amagnetic sensor can be used for tracking the syringe and/or provideinformation related to a position (for example, three-dimensionalposition) of the syringe.

FIG. 11A illustrates schematically a syringe 1100 having a magneticsensor. The syringe 1100 can have any of features of the syringe 100,400, 1000. Features of the syringe 100, 400, 1000 can be incorporatedinto features of the syringe 1100 and features of the syringe 1100 canbe incorporated into features of the syringe 100, 400, 1000.

The magnetic sensor can include a magnet and a magnetic field sensor, ormagnetometer. A magnetic chip 1152 can be located on the syringe body1130 near the needle 1150, for example, on or near a distal end of thesyringe body 1130. A position of the magnetic chip 1152 can bedetermined by an external magnetic field sensor and provided to thecontroller of the injection system. The external magnetic field sensorcan have a predetermined physical locational relationship with aphysical area of interest, for example, the training apparatus or a livepatient. Information of the position of the magnetic chip 1152 can beconfigured to provide tracking of movements of the syringe 1100 (forexample, in a three-dimensional space) relative to the magnetic fieldsensor.

A second magnet chip can also be positioned at a different location onthe syringe. For example, the second magnetic sensor can be positionedon the syringe body near the flange 1134 or closer to the flange 1134than the magnetic chip 1152 shown in FIG. 11. The controller can usepositional data of the two magnetic chips to determine an attitude ofthe syringe.

The magnetic chip can be more compact than the optical sensor. A needleof a smaller cross-sectional diameter (higher gauge number, such as agauge 30 needle) can be used with the magnetic chip than a needleconfigured for accommodating the optical sensor inside the needle. Todetect the light source from the needle, one or more light detectors arerequired inside the training apparatus. It can be difficult to fit theplurality of light detectors inside the training apparatus. The magneticchip(s) can be used without additional detectors internal to thetraining apparatus. The magnetic field detector can be located externalto the training apparatus and/or the syringe. A magnetic chip can thusbe used to provide positional information about the needle inside both alive patient and a training apparatus, whereas a light source near theneedle tip may not be able to provide positional information about theneedle inside the patient.

The magnetic chips(s) can replace or be used in conjunction with anoptical sensor in the needle. The syringe can include both the magneticchip(s) and the optical sensor. Data from the magnetic chip(s) can beconfigured to overlay the three-dimensional data obtained from internalsensors in the syringe and/or the training apparatus, such as the lightsource in the needle tip captured by light detectors inside the trainingapparatus and/or the position sensors. The combination of data can beconfigured for building a neural network enabling deep leaning of thecontroller and/or the remote server of the injection system from thecombination of data.

External Camera(s)

The injection system can optionally include one or more cameras 240 (seeFIG. 1B), for example, depth cameras, located outside the trainingapparatus or external to the live patient to record an injectionprocedure. The external camera can be the Microsoft HoloLens worn by auser. Data from the HoloLens can be sent to a processor configured toprocess the data at a rate sufficient for tracking the syringe duringthe injection procedure, and/or to a neural network.

The external cameras can provide computer vision, which can includeacquiring, processing, analyzing and/or understanding digital imagestaken by the external cameras. The external cameras can recognize alocation of the training apparatus or the live patient in athree-dimensional space and/or certain locations on the trainingapparatus or the live patient, such as facial recognition. Data from theone or more external cameras can be configured to overlay thethree-dimensional data obtained from the sensors in the syringe and/orthe training apparatus, such as the light detection features and/or theposition sensors, and/or data obtained from the magnetic sensor(s). Thecombination of data can be configured for building a neural networkenabling deep learning of the processor. The data recorded by theexternal cameras can also be used as ground truth reference data for thethree-dimensional data based on the sensors in the syringe and/or thetraining apparatus.

The external cameras can be used to record data of an injectionprocedure performed on a live patient. The external cameras can be usedwith a head band, and/or glasses, such as described in U.S. PatentPublication No. 2017/0178540 A1, filed on Dec. 22, 2016 and entitled“INJECTION TRAINING WITH MODELED BEHAVIOR,” which is incorporated byreferenced herein in its entirety, or a helmet fixture described below,which can mark anatomical landmarks and/or injection target locations. Ascanner device, such as described in U.S. Patent Publication No.2017/0245943 A1, filed on Feb. 27, 2017 and entitled “COSMETIC ANDTHERAPEUTIC INJECTION SAFETY SYSTEMS, METHODS, AND DEVICES,” which isincorporated by referenced herein in its entirety, can be configured todetermine locations of arteries, veins, and/or nerves underneath thepatient's skin. The head band, glasses, helmet, and/or scanner devicecan be used in combination with the external cameras to provide computervision.

FIG. 11B illustrates an example flow chart for a method of determiningthe syringe position and/or orientation. At step 1170, the controllercan optionally determine whether the SDPA is mounted to the syringeflange. For example, the controller can determine that the SDPA has beenmounted to the syringe upon detection of a medication code on the flangeby the medication code reader described herein. If the SDPA has not beenmounted to the syringe flange, at step 1172, the controller can outputan instruction to a user, such as an injector or a nurse, to mount theSDPA to the syringe. If the SDPA has been mounted to the syringe flange,at step 1174, the controller can receive a signal from a first positionand/or orientation sensor. At step 1176, the controller can receive asignal from a second position and/or orientation sensor. The firstand/or second position and/or orientation sensor can include an inertialnavigation system, an internal optical sensor including the light sourcein the syringe and one or more camera(s) inside the training apparatus,an external optical sensor such as one or more externa cameras, and/orone or more magnetic sensors. At step 1178, the controller can determinethe current position and/or orientation of the syringe based at least inpart on the signal from the first or second sensor, or a combination ofthe signals from the first and second signals.

Needle-in-Artery Detection

The injection system can include warning features when a needle tippenetrates and/or is inside an artery. Injecting certain materials intoan artery, such as filler materials in cosmetic facial injections,therapeutic injections, and/or orthopedic procedures (such as a kneesurgery), can occlude the artery. Some materials can be used to bulk upfacial features for an extended period and can have high viscosity toreduce the chance of migration and prolong the effective life of thematerials. The viscosity of some materials can be higher than the blood(such as the arterial blood). When injected into the artery, thematerials can block the blood flow in the artery. Occluding the arterycan be harmful to the patient, leading to blindness, tissue death,and/or other negative consequences.

A pressure applied on the plunger and the plunger travel can bemonitored, using methods as described herein, to reduce the risk of aneedle tip inside an artery. The flow of injection material(s) from theneedle tip can be attenuated based on an arterial blood pressure of thepatient when the tip penetrates the arterial wall. The injection systemcan be configured to control the fluid pressure at the needle tip suchthat the flow from the needle tip can be stopped if the tip is immersedin an environment at an elevated pressure.

As shown in FIG. 12A, if the needle 1250 is inside an artery 32, the tipof the needle 1250 can be surrounded by a blood flow at an arterialpressure. A diastolic blood pressure can be about 60 to about 80 mm Hgfor a healthy adult patient. A systolic blood pressure can be about 80to about 120 mm Hg for a healthy adult patient. Injection targetlocations in the patient's body can have a lower pressure than thelowest arterial pressure, such as the diastolic pressure of the patient.

In order for the injection material(s) 20 to flow from the syringe body1230, through the needle 1250, into the tissue, the pressure of thematerial(s) 20 exiting the needle 1250 needs to be higher than anambient pressure adjacent to but external to the needle tip. If theambient pressure is equal to or greater than the injection material(s)pressure, the flow of injection material(s) 20 from the needle 1250 tothe surrounding can stop. The flow can also reverse in direction in somesituations.

The pressure of the material(s) exiting the needle 1250 can besubstantially the same as a pressure applied by an injector 30 on theplunger 1210. The pressure can be a static pressure. The pressureapplied on the plunger 1210 can be measured by a variety of methods. Forexample, the pressure can be measured by a pressure sensor. The pressureapplied on the plunger 1210 can also be calculated from a force on theplunger 1210 measured by a force sensor. The force sensor can be locatedon the thumb portion of the plunger 1210 or elsewhere on the syringe1200. The pressure of the injection material(s) 20 inside the syringebody 1230 can be equal to the force on the plunger 1210 divided by asurface area of the thumb portion of the plunger 1210.

As the injection material(s) 20 flow(s) through the needle 1250, thepressure of the injection material(s) 20 drops. FIG. 12B illustratesschematically a pressure profile for a flow of medication exiting asyringe into flesh and calculation of a pressure applied to injectionmaterial(s) inside a syringe body. A small needle bore, a long needle,and/or a fast flow of the injection material(s) can lead to morepressure drop than a large needle bore, a short needle, and/or a slowflow of the injection material(s). The force applied to the plunger cantypically be from about zero to about 89 N. The surface area of thethumb portion can be about 77.4 mm square. The pressure of the injectionmaterial(s) can typically be about 1.1 MPa or about 11 atmospheres.

The injection system can have a needle-in-artery detection feature byapplying a pressure significantly lower than a typical pressure appliedto the plunger (for example, at about 1.1 MPa or about 11 atmospheres).The system can monitor the needle tip pressure, or instruct the user toprovide a pressure on the plunger, such that the pressure is less thanthe lowest arterial blood pressure of the patient (such as the diastolicblood pressure). The controller can monitor travel of the plunger, usingmethods such as described herein, when the low pressure is applied.

By adjusting a force or pressure (such as a static force or pressure)applied to the plunger and monitoring the travel of the plunger, thepressure of the injection material(s) at the needle tip can becontrolled. FIG. 12 illustrates an example process for detecting whetherthe needle has penetrated and/or is in the artery. The process describedherein can then be followed by a conventional injection procedure with anominal medication injection volume and injection rates. In the flowchart shown in FIG. 12C, at step 1270, the controller can control theneedle tip pressure and/or instruct the user to apply a needle tippressure that is lower than a predetermined blood pressure. Thepredetermined blood pressure can be the lowest arterial blood pressureof a patient. By controlling the needle tip pressure such that it isless than the lowest arterial blood pressure of the patient (such as thediastolic blood pressure), the flow of injection material(s) from needletip into the artery can be stopped. The injection material(s) can beprevented from entering into the artery and the risk of arterialblockage due to the injection material(s) can be reduced and/or avoided.

At step 1271, the controller can receive signals from the plunger travelsensor as described herein. At decision step 1272, the controller candetermine whether the plunger has been advanced distally relative to thesyringe body as described above. If a plunger travel is detected, atstep 1273, the controller can optionally output an indication that theneedle is likely not in an artery. At step 1274, the controller canoutput an instruction for the injector to continue with the injection.If a plunger travel is not detected, at step 1275, the controller canoptionally output an indication that the needle tip is inside a highpressure environment, which may or may not be an artery. At decisionstep 1276, the controller can optionally determine whether no distalplunger travel is detected for a certain duration and/or when theplunger travels proximally away from the needle. If the plunger has notmoved distally for the predetermined amount of time and/or if theplunger has moved proximally, at step 1277, the controller can output awarning that the needle is inside an artery. If distal plunger travel isdetected within the predetermined amount of time, the controller canreturn to step 1271.

The injection system can also have indicator features for informing thepatient and/or the injector whether the needle tip is inside an artery.The indicator features can be on the syringe, on a display device,and/or elsewhere in a room in which the injection procedure isperformed. The indicator features can have a plurality of coloredlights. The display device can run an application or software to displaythe last injection site (such as on the patient's face) so that theinjector can go in to the last injection site promptly to search forocclusion(s). The indicator features can also include instructions tothe injector to use a solvent or any other product to remove theocclusion. The solvent can comprise hyaluronidase, such as Hylenex orVitrase. When the pressure applied to the plunger is at or slightlylower than the lowest arterial pressure of the patient, the system canswitch on a green light when the plunger travel is detected (forexample, for a certain duration) and/or when the plunger travel speedexceeds a predetermined threshold value. The green light can indicatethat the needle is not inside an artery. The system can switch on ayellow light if no travel of the plunger is detected. No plunger traveldetection can indicate that the needle tip is inside a high pressureenvironment, which may or may not be an artery. The system can switch ona red light if no plunger travel is detected for a certain durationand/or when the plunger travels proximally away from the needle. The redlight can indicate that the needle is inside an artery. The system canoptionally switch on the red light without showing a yellow light. Thesystem can also instruct the trainee or injector to push the needlefurther to completely go through the artery and/or to pull back theneedle to move to a new location. Different color schemes can be used toprovide warning to the user. Audio signals can also be used as theindicators, or lights, audio signals, and/or haptic feedback featurescan be used as a combination of indicators.

Charging Base

The injection system can include a charging station for recharging thepower source, such as a rechargeable battery, on the SDPA. FIG. 13illustrates an example charging station 300. FIG. 14A illustratesanother example charging station 500 with a slightly different outershape. The charging station 300, 500 can include a generally T-shapedcradle 302, 502 shaped for receiving the syringe body, which can be anyof the syringe bodies described herein. A short side 312, 512 of thecradle 302, 502 can accommodate the flange of the syringe body,including the SDPA described herein. A long side 311, 511 of the cradle302, 502 can accommodate the body portion of the syringe. One or moreelectrical contacts 304, 504, such as pogo pins, can be positioned inthe cradle 302, 502. As shown in FIGS. 13 and 14A-B, the electricalcontacts 304, 504 can each be located at a juncture of the short andlong sides of the cradle 302, 502. The electrical contacts 304, 504 cancome into contact with electrical pads on the flange base, such as thepads 437 in FIGS. 4A and 9B. The electrical contacts can be located onanother portion of the charging base. The electrical pad can be locatedon another part of the syringe.

As shown in FIG. 14B, the electrical contacts 504 can each have a pogopin 506 extending into the charging station 500. When the pogo pins 504make contact with the electrical pads 437, the pogo pins 504 can connectthe SDPA of the syringe to a charging circuit so as to charge the powersource in the syringe. The charging station 300 in FIG. 13 can have acharging circuit configured to be connected to an external power sourcevia a power cord 308. The charging station 500 in FIGS. 14A-B can have acharging circuit configured to be connected to an external power sourcevia a USB port 508.

Home Cradle

The injection system can include a home cradle for providing an initialposition for the syringe. FIG. 15 illustrates an example home cradle600. The cradle 600 can be configured to support any of the syringesdescribed above, such as the syringe 100. The cradle 600 can be attachedreleasably or permanently to a helmet fixture 700. The helmet fixture700 can also be a headband or any other fixture that can be releasablyattached to the injection location. The helmet fixture 700 can be wornby a live patient or the training apparatus. The helmet fixture can alsobe any other type of fixture that can be secured to the live patient orthe training apparatus.

When the helmet fixture 700 is worn on the patient's head or thetraining apparatus, a position of the syringe held by the home cradle600 can be taken to provide the initial position of the syringe. Theposition and/or location of the syringe 100 after the syringe 100 hasbeen removed from the cradle 600 can be determined using the positionsensor on the SDPA, the light detectors inside the training apparatus,and/or other sensors described herein.

Terminology

Although this disclosure has been described in the context of certainembodiments and examples, it will be understood by those skilled in theart that the disclosure extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof. In addition, while severalvariations of the embodiments of the disclosure have been shown anddescribed in detail, other modifications, which are within the scope ofthis disclosure, will be readily apparent to those of skill in the art.It is also contemplated that various combinations or sub-combinations ofthe specific features and aspects of the embodiments may be made andstill fall within the scope of the disclosure. For example, featuresdescribed above in connection with one embodiment can be used with adifferent embodiment described herein and the combination still fallwithin the scope of the disclosure. It should be understood that variousfeatures and aspects of the disclosed embodiments can be combined with,or substituted for, one another in order to form varying modes of theembodiments of the disclosure. Thus, it is intended that the scope ofthe disclosure herein should not be limited by the particularembodiments described above. Accordingly, unless otherwise stated, orunless clearly incompatible, each embodiment of this invention maycomprise, additional to its essential features described herein, one ormore features as described herein from each other embodiment of theinvention disclosed herein.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example described inthis section or elsewhere in this specification unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The protection is notrestricted to the details of any foregoing embodiments. The protectionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Furthermore, certain features that are described in this disclosure inthe context of separate implementations can also be implemented incombination in a single implementation. Conversely, various featuresthat are described in the context of a single implementation can also beimplemented in multiple implementations separately or in any suitablesubcombination. Moreover, although features may be described above asacting in certain combinations, one or more features from a claimedcombination can, in some cases, be excised from the combination, and thecombination may be claimed as a subcombination or variation of asubcombination.

Moreover, while operations may be depicted in the drawings or describedin the specification in a particular order, such operations need not beperformed in the particular order shown or in sequential order, or thatall operations be performed, to achieve desirable results. Otheroperations that are not depicted or described can be incorporated in theexample methods and processes. For example, one or more additionaloperations can be performed before, after, simultaneously, or betweenany of the described operations. Further, the operations may berearranged or reordered in other implementations. Those skilled in theart will appreciate that in some embodiments, the actual steps taken inthe processes illustrated and/or disclosed may differ from those shownin the figures. Depending on the embodiment, certain of the stepsdescribed above may be removed, others may be added. Furthermore, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure. Also, theseparation of various system components in the implementations describedabove should not be understood as requiring such separation in allimplementations, and it should be understood that the describedcomponents and systems can generally be integrated together in a singleproduct or packaged into multiple products.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. Not necessarily all such advantages maybe achieved in accordance with any particular embodiment. Thus, forexample, those skilled in the art will recognize that the disclosure maybe embodied or carried out in a manner that achieves one advantage or agroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

Conditional language used herein, such as, among others, “can,” “could,”“might,” “may,” “e.g.,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isgenerally intended to convey that certain embodiments include, whileother embodiments do not include, certain features, elements and/orsteps. Thus, such conditional language is not generally intended toimply that features, elements and/or steps are in any way required forone or more embodiments or that one or more embodiments necessarilyinclude logic for deciding, with or without other input or prompting,whether these features, elements and/or steps are included or are to beperformed in any particular embodiment. The terms “comprising,”“including,” “having,” and the like are synonymous and are usedinclusively, in an open-ended fashion, and do not exclude additionalelements, features, acts, operations, and so forth. Also, the term “or”is used in its inclusive sense (and not in its exclusive sense) so thatwhen used, for example, to connect a list of elements, the term “or”means one, some, or all of the elements in the list.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than 10% of, within less than 5% of, within less than 1% of, withinless than 0.1% of, and within less than 0.01% of the stated amount. Asanother example, in certain embodiments, the terms “generally parallel”and “substantially parallel” refer to a value, amount, or characteristicthat departs from exactly parallel by less than or equal to 15 degrees,10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.

Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “applying a pressure” include “instructing applicationof a pressure.”

All of the methods and tasks described herein may be performed and fullyautomated by a computer system. The computer system may, in some cases,include multiple distinct computers or computing devices (e.g., physicalservers, workstations, storage arrays, cloud computing resources, etc.)that communicate and interoperate over a network to perform thedescribed functions. Each such computing device typically includes aprocessor (or multiple processors) that executes program instructions ormodules stored in a memory or other non-transitory computer-readablestorage medium or device (e.g., solid state storage devices, diskdrives, etc.). The various functions disclosed herein may be embodied insuch program instructions, and/or may be implemented inapplication-specific circuitry (e.g., ASICs or FPGAs) of the computersystem. Where the computer system includes multiple computing devices,these devices may, but need not, be co-located. The results of thedisclosed methods and tasks may be persistently stored by transformingphysical storage devices, such as solid state memory chips and/ormagnetic disks, into a different state. In some embodiments, thecomputer system may be a cloud-based computing system whose processingresources are shared by multiple distinct business entities or otherusers.

The scope of the present disclosure is not intended to be limited by thespecific disclosures of preferred embodiments in this section orelsewhere in this specification, and may be defined by claims aspresented in this section or elsewhere in this specification or aspresented in the future. The language of the claims is to be interpretedbroadly based on the language employed in the claims and not limited tothe examples described in the present specification or during theprosecution of the application, which examples are to be construed asnon-exclusive.

1-109. (canceled)
 110. A flange configured for use on an injectionsyringe, the flange comprising: a flange housing, wherein the flangehousing includes an internal compartment; and at least one circuit boardmounted within the internal compartment, wherein the at least onecircuit board comprises one or more sensors, the one or more sensorsconfigured to measure injection information about an injection procedureperformed using the injection system.
 111. The flange of claim 110,comprising a flange base and a flange cover, wherein the flange base andflange cover are configured to be assembled to form the internalcompartment.
 112. The flange of claim 111, wherein the flange base is anintegral part of a syringe body, the flange cover comprising one or moreslots configured to slidably accommodate the flange base.
 113. Theflange of claim 111, wherein the flange base comprises a slot on adistal surface, the slot configured to slidably accommodate a flangeportion of the syringe.
 114. The flange of claim 110, wherein the flangecomprises an opening sized to accommodate a plunger of the syringe. 115.The flange of claim 110, wherein the at least one circuit boardcomprises a plunger travel sensor, a force sensor, a pressure sensor,and/or a medication code reader.
 116. An injection system, the systemcomprising: a syringe having a syringe body and a plunger, the plungerconfigured to move relative to the syringe body, the syringe bodyconfigured to be coupled to a needle; the syringe body comprising a bodyportion having a proximal end and a distal end, and a needle couplingportion disposed at or near the distal end; and the flange of claim 110.117. The system of claim 116, wherein the injection informationcomprises one or more of: time of injection; type of medication;authenticity of medication; injection dose; identity of user of thesystem; and/or location of injection.
 118. The injection system of claim116, wherein the system is configured for providing injection to a livepatient and/or a training apparatus.
 119. An injection system, thesystem comprising: a syringe having a syringe body and a plunger, thesyringe body configured to be coupled to a needle, the plungerconfigured to move relative to the syringe body, wherein the plungercomprises a plunger shaft having a helical groove along a longitudinalaxis of the plunger shaft; the syringe body comprising a body portionhaving a proximal end and a distal end, a flange disposed at or near theproximal end, and a needle coupling portion disposed at or near thedistal end; and a plunger travel sensor disposed on the flange, whereinthe plunger travel sensor comprises an opening sized and shaped toslidably engage the plunger shaft so that the plunger travel sensorrotates along the helical groove as the plunger shaft moves axiallyalong the longitudinal axis of the plunger shaft, and wherein theplunger travel sensor is configured to measure an axial plunger traveldistance based on an amount of rotation of the plunger travel sensor.120. The injection system of claim 119, wherein the plunger shaftcomprises a generally D-shaped transverse cross-section.
 121. Theinjection system of claim 119, wherein the plunger travel sensorcomprises a bearing configured to rotate along the he helical groove asthe plunger shaft moves axially along the longitudinal axis of theplunger shaft.
 122. The injection system of claim 121, wherein theplunger travel sensor is configured to measure the axial plunger traveldistance based on an angular position of the bearing.
 123. The injectionsystem of claims 119, wherein the plunger shaft comprises a channelrunning substantially parallel to the longitudinal axis, and wherein theplunger travel sensor comprises a radially inward protrusion configuredto engage the channel when the plunger shaft moves axially, theprotrusion remaining stationary when the plunger shaft moves axially.124. The injection system of claim 119, wherein the system is configuredto calculate a dose measurement based at least in part on the axialplunger travel distance.
 125. An injection system, the systemcomprising: a syringe having a needle, the needle comprising an opticfiber disposed within a lumen of the needle, the optic fiber terminatingdistally at or near a tip of the needle; the syringe further comprisinga syringe body and a plunger, the plunger configured to move axiallyrelative to the syringe body; and the syringe body comprising a bodyportion having a proximal end and a distal end, a flange portion at theproximal end, and a needle coupling portion disposed at or near thedistal end, the syringe body further comprising a light source disposedat or near the distal end; wherein when the needle is coupled to theneedle coupling portion of the syringe body, the optic fiber is coupledto a power source so as to direct light emitted by the light source outthrough the tip of the needle, the power source also configured to powerthe light source.
 126. The injection system of claim 125, wherein theoptic fiber extends proximally from a proximal end of the needle. 127.The injection system of claim 125, wherein the optic fiber is fused withthe lumen of the needle.
 128. The injection system of claim 125, whereinthe needle is releasably coupled with the needle coupling portion by M3threads.
 129. The injection system of claim 125, wherein the powersource is mounted to the flange portion, the syringe body portioncomprising a wire lumen, one or more lead wires extending from the powersource through the wire lumen, the one or more lead wires terminating ator near the distal end of the syringe body portion.